The overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a myocardial infarction (MI).

Change in Depression (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after intervention) ] [ Designated as safety issue: No ]

Hospital Anxiety and Depression Scale (HADS) - depression ratings;

Montgomery Åsberg Depression Rating Scale (MADRS)

Change in Anxiety (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after intervention) ] [ Designated as safety issue: No ]

Hospital Anxiety and Depression Scale (HADS) - anxiety ratings

Secondary Outcome Measures:

Change in Quality of Life (difference between the intervention and the control group) [ Time Frame: At baseline, during, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Ratings on EQ5d and Ladder of Life (LL)

Change in Perceived Social Support (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

ENRICHED Social Support Inventory (ESSI)-ratings

Change in Stress behaviors (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Everyday Life Stress Scale (ELSS)-ratings

Change in Fatigue (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Maastricht Questionnaire (MQ)-ratings

Change in Cardiac Anxiety (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Cardiac Anxiety Questionnaire (CAQ)-ratings

Change in Sleeping Problems (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Insomnia Severity Index (ISI)-ratings

Change in Posttraumatic Stress (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Change in Posttraumatic Growth (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

The Posttraumatic Growth Inventory ‐ Short Form (PTGI-SF)-ratings

Quality of the Intervention [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Behavioral Activation for Depression Scale (BADS)-ratings

Change to Follow-up in Anxiety (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Hospital Anxiety and Depression Scale (HADS) - anxiety ratings

Change to Follow-up in Depression (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]

Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet‐based CBT‐program.

Behavioral: Internet‐based CBT

The participants read texts and do weekly homework assignments instructed from an Internet page. Additional resources like discussion forum, pictures, animations, videos and sounds will be a part of the treatment program.

A psychologist will communicate with the participants through internal text‐messages. The therapist will devote about 10 minutes to each participant each week via the Internet. The content of the intervention will be standard components from CBT, for example relaxation training, behavioral activation, exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment etc.

No Intervention: Treatment as usual (TAU)

Control: After randomization patients with symptoms of anxiety and/or depression after MI will participate in the treatment as usual (TAU).

Reference: A reference group without depressive or anxiety symptoms will participate in the treatment as usual (TAU).

Detailed Description:

Major or minor depressive disorders and anxiety disorders are present in many patients with cardiovascular disease (CVD) and are associated with adverse cardiovascular outcomes, even after controlling for other risk factors. 500 patients with symptoms of anxiety and/or depression after MI will be randomized either to a 14 week Internet-based CBT-program or to treatment as usual (TAU) which is the control condition. A reference group of 250 participants without depressive or anxiety symptoms will also be studied during TAU. Data will be collected before, after and 7 months after treatment. Anxiety and depression according to ratings on the Hospital Anxiety and Depression Scale (HADS) are the primary outcome measures.

Eligibility

Ages Eligible for Study:

up to 75 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients younger than 75 years with a recent acute MI (< 3 months)

Depression and/or anxiety score of > 7 on one or both of the HADS subscales (concerns only the intervention, not the reference group)

Exclusion Criteria:

Patients that are scheduled for a coronary artery bypass surgery (CABG)

Unable or unwilling to use computer or Internet

Difficulties in reading or understanding Swedish

A life expectancy of less than a year

Anticipated poor compliance (multi‐disease, substance abuse etc.)

Highly depressed or suicidal (MADRS‐score > 29 or MADRS item 9 > 3)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504191